Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects

Elderly, Frail Clinical Trial

Official title:

Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00249704
• Other study ID #: A9001116
• Status: Terminated
• Phase: Phase 1
• First received: November 3, 2005
• Last updated: January 7, 2009
• Start date: October 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.

Description:

The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion Criteria:

• Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly, Frail

Intervention

Drug:
• Vitamin D + Sham Exercise
1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise

Procedure:
• Vitamin D Placebo + Exercise
Vitamin D placebo + Exercise
• Vitamin D Placebo + Sham Exercise
Vitamin D placebo + Sham (equivalent to placebo) Exercise

Drug:
• Vitamin D + Exercise
1000 IU per day of Vitamin D + Exercise

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Farmington	Connecticut
United States	Pfizer Investigational Site	Hyattsville	Maryland
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Roslindale	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.		Throughout trial	No
Secondary	Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.		throughout trial	No

External Links

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